Treatment of Pruritus With Intramuscular Promethazine
Completed · Phase 4 · Has a placebo group
Conditions studied: Pruritus, Pregnancy Related
In brief
Neuraxial narcotics are commonly used in obstetric patients for cesarean delivery to help with pain control over the first 24 hours after the surgery. The aim is to evaluate effectiveness of promethazine (IMP) treatment of intrathecal morphine induced pruritus (ITIMIP). A treatment for ITMIP, other than naloxone, will allow for increased use of intrathecal narcotics and decrease the use of systemic opioids in the initial post-operative period.
Key facts
- Study ID
- NCT04805073
- Run by
- University of Florida
- People needed
- 72
- Starts
- 2021-08-09
- Expected to finish
- 2024-05-30
- Last updated by the study team
- 2025-05-04
Who can join
Age: 18 and older, up to 99. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Pregnant adult female patients of at least 18 years of age consenting to a cesarean birth
- Willing to consent to study.
You may not qualify if…
- Male patients
- Incarceration
- Inability to communicate with the investigators
- Allergies to any medications used in the study
- Possessing any contraindication to spinal anesthesia (lack of consent, elevated intracranial pressure, preexisting neurological disease, thrombocytopenia/coagulopathy, hypovolemia, infection at the site of the procedure)
- Patients with an already prolonged QTc (>500 ms)
- Any reason an investigator believes study participation would not be in the best interest of the potential subject.
Where it is running
- UF Health at the University of Florida — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.